WO1996029962A1 - Catheter a condom male en deux parties et procede de fabrication de ce catheter - Google Patents

Catheter a condom male en deux parties et procede de fabrication de ce catheter Download PDF

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Publication number
WO1996029962A1
WO1996029962A1 PCT/US1995/007978 US9507978W WO9629962A1 WO 1996029962 A1 WO1996029962 A1 WO 1996029962A1 US 9507978 W US9507978 W US 9507978W WO 9629962 A1 WO9629962 A1 WO 9629962A1
Authority
WO
WIPO (PCT)
Prior art keywords
sheath
mils
mandrel
condom catheter
male condom
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1995/007978
Other languages
English (en)
Inventor
Richard E. Stehr
Keith G. Munson
Thomas P. Kubalak
Daniel P. Welch
Roger J. Woessner
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mentor Worldwide LLC
Original Assignee
Mentor Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mentor Corp filed Critical Mentor Corp
Priority to EP95925301A priority Critical patent/EP0817601A1/fr
Priority to AU29482/95A priority patent/AU704557B2/en
Priority to JP8529305A priority patent/JPH11502736A/ja
Publication of WO1996029962A1 publication Critical patent/WO1996029962A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/451—Genital or anal receptacles
    • A61F5/453—Genital or anal receptacles for collecting urine or other discharge from male member

Definitions

  • the present invention relates generally to a male external catheter, or condom catheter, and more particularly, to an external male catheter including a bio-compatible polyurethane sheath integrally affixed to a polyvinylchloride conical portion and a method for making the male condom catheter.
  • a sheath of flexible material placed over the penis and connected to the receptacle with a tube or other form of flexible conduit. Since urinal devices must be worn for extended periods of time, it is customary for the sheath of such devices to be flexible to allow for patient comfort. It is also desirable for the sheath to possess high moisture transmission properties because some patients develop skin irritations such as swelling, rashes, sores, etc. due to skin contact with excess moisture, nitrates and protein constituents from urine decomposition as well as from chemicals contained in commonly used materials known in the art, such as rubber latex, for example. U.S.
  • Patent No. 4,475,910 entitled Male Condom Catheter Having Adhesive Transfer On Roller Portion, to Conway ct al. discloses a male urinal device having a laminated sheath with an inner layer of latex rubber and an outer layer of silicone rubber. Adhesive is stored between the inner and outer layers when the sheath is rolled. As the sheath is unrolled about a penis, adhesive is released from the outer layer and adheres to the inner layer. Upon pressing the sheath to the penis, a leak-free bond is created.
  • U.S. Patent No. 4,885,049 entitled Method of Manufacture of an External Catheter for Male Urinary Incontinence, to Johannesson (hereinafter " '049”) discloses a method of making an external male urinal device having a body portion, including an internal adhesive component and an external cover layer; both are prefabricated components. This disclosure specifically avoids the use of components in a liquid state. Further, the body portion, or sheath, is manufactured as a soft, thin-walled single layer component, preferably latex or synthetic rubber.
  • U.S. Patent No. 5,376,085. entitled External Urinary Catheter having Integral Adhesive Means, to Conway et al. discloses a method of making a male external silicone catheter having an integral acrylic adhesive affixed to the catheter during processing.
  • the adhesive must be of the type that at least partially cross-links with the silicone catheter during a vulcanization step which occurs when the silicone catheter is in contact with the adhesive. The silicone and the adhesive will contact the skin during use.
  • U.S. Patent No. 4,626.250 entitled Male Urinary Collection System and External Catheter Therefor, to Schneider (hereinafter " '250”) discloses an external male urinal device and a method for making the same, wherein the catheter is formed in a dipping process which includes a preliminary step of stretching a pre-formed tubular member over a dipping form.
  • the end of the tubular form which is to become a distal tapered opening is treated so that latex will not adhere thereto upon dipping the remainder of the tubular form in a latex bath to form the outer sheath.
  • the adhesive pad is preferably a synthetic or natural rubber and can also be improved with a minor proportion of polyacrylamide resin. These chemicals will come to rest on the skin upon application of the catheter to a patient.
  • Silicone catheters such as (CLEAR ADVANTAGE)TM by the Mentor Corporation, are of tremendous appeal to users because the skin beneath the condom catheter is visible through the sheath. However, some patients' skin also macerate due to low moisture transmission of the silicone. In order to address patients experiencing skin maceration accompanying the use of silicone condom catheters or to address allergic reactions to rubber latex condom catheters, it is desirable to utilize a catheter which exhibits high moisture transmission and a low level of chemicals inherent in the sheath material.
  • the cone portion must be flexible enough to withstand insertion of a connecting portion to the receptacle but yet be durable enough to withstand pressure due to excess urinary pressure which may accumulate within the catheter. It is further desirable that the sheath and the cone portion be integrally affixed to one another to eliminate leakage.
  • the present invention overcomes the apparent problems and attendant disadvantages associated with male condom catheters formed from rubber latex, other synthetic rubber products or silicone.
  • the present invention is directed to a male external condom catheter that addresses the incontinence management needs of male patients who arc sensitive to rubber latex, silicone or other rubber materials. More particularly, the preferred embodiment of the present invention includes a condom catheter having a cone portion which is then dipped into a liquid-state polyurethane bath thus forming a sheath which is integrally affixed to the cone portion.
  • the present device is particularly advantageous in that the polyurethane sheath effectively eliminates the skin irritation problems normally associated with rubber latex sensitivity and skin breakdown due to excess moisture.
  • Another feature of the present device is that it retains the feel, structure and inherent flexibility characteristics of rubber latex, silicone or other rubbers. Still another feature is the clear colorless appearance desired by physicians and consumers. A release coating and an adhesive may also be applied to the sheath surface.
  • the lowest practicle manufacturing limit for sheath thickness is less than half of the lowest pratical limit for standard silicone sheath thickness.
  • the thinner polyurethane sheath of the present invention has increased "breathability,” durability, user comfort and ease in examining skin condition beneath the sheath without sheath removal.
  • the present invention includes a method for making a male condom catheter device.
  • the method comprises placing a cone portion having tube end opposing a cone end on a mandrel forming a mandrel set, dipping the mandrel set into a liquid-state polyurethane bath such that polyurethane coats the cone and extends onto the mandrel, curing the polyurethane coated mandrel set and repeating the dipping and curing steps to obtain a desired sheath thickness.
  • FIG.l is a perspective view of a male condom catheter device of the present invention.
  • FIG.2 is a flow diagram indicating the method for making the male condom catheter in accordance with the present invention.
  • a male condom catheter in accordance with the present invention is designated generally as 10.
  • Device 10 is preferably comprised of a condom portion in the form of a sheath or a sleeve 15 integrally affixed to a conical portion 17 at cone 19.
  • Conical portion 17 more preferably includes cone 19 merging with a surge chamber/anti-kink mechanism 21 which then merges with a neck 23.
  • Neck 23 connects with a tube 24.
  • Surge chamber/anti-kink mechanism 21 may also serve as a backflow prevention device for tube 24, which is then connected to a urine collection receptacle via flexible conduit or tubing (not shown) .
  • device 10 is not limited to the particular embodiment illustrated, and that other combinations of elements including, but not limited to, constrictions and bulbous surge chambers can be added to device 10 without departing from the spirit and scope of the present invention.
  • Such elements, including those illustrated in FIG. 1, may assume various shapes or be arranged in an order other than that illustrated.
  • male condom catheter device 10 is made by placing conical portion 17, which is typically supplied as a single piece PVC form from various suppliers including, but not limited to, F & M Plastics for example, onto a mandrel wherein the taper of cone 19 fits tightly against the mandrel, forming a mandrel set with the mandrel.
  • conical portion 19 such as silicone, polyurethanes, styrenebutadienes or other clear thermoplastic rubbers.
  • the mandrel set is then heated from between about 90 deg. C. to about 100 deg. C, most preferably about 95 deg. C.
  • the mandrel set is heated for about 10 minutes.
  • the heated mandrel set is dipped into a liquid-state polyurethane bath.
  • the polyurethane bath is held at a temperature between about 18 deg. C. to about 24 deg. C, preferably about 21 deg. C.
  • the mandrel set is dipped to a depth corresponding to a desired sheath length.
  • Polyurethane utilized in the present embodiment is "AUKUFLEX Al 11"TM from Aukland Medical Plastics, Inc. Other polyurethane suitable for medical purposes may also be utilized.
  • the mandrel set is then withdrawn from the bath at a predetermined rate such that a sheath is formed on the mandrel set.
  • the predetermined rate of about 10 inches per minute is utilized in the present embodiment. This withdrawal rate forms a sheath thickness of about 1.75 mils.
  • the mandrel set including the sheath is cured by first heating and then by cooling to ambient temperature.
  • curing is accomplished by heating the mandrel set including the sheath preferably from between about 80 deg. C. to about 100 deg. C. for a predetermined time, most preferably heating at about 90 deg. C. for about 20 minutes. It will be understood that there is no air current while heating takes place as the current will tend to disturb the integrity of the forming sheath.
  • the mandrel set including the sheath is then cooled at room temperature for about 5 minutes.
  • the mandrel set including the sheath may be dipped and cured multiple times until desired sheath thickness is achieved.
  • the sheath thickness is preferably between about 1.75 mils, to about 9 mils., as sheaths having a thickness thinner than 1.75 mils, are prone to tearing and those thicker than 9 mils, will not possess the flexibility required for patient comfort. More preferably the sheath thickness is within the range from between about 2 mils, to about 8 mils., and most preferably between about 3 mils, to about 4 mils. A release coating and an adhesive may also be applied to the sheath prior to removal of condom catheter 10 from the mandrel.
  • the polyurethane sheath is up to about 5 times more stretchable and durable than the silicone sheath, as shown by the percent elongation and the pounds per square inch required to break the sheath upon stretching. Therefore, the polyurethane sheath is stronger, more moisture vapor transmissive and yet is less than half as thick as the silicone sheath.

Landscapes

  • Health & Medical Sciences (AREA)
  • Reproductive Health (AREA)
  • Epidemiology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

L'invention concerne un cathéter à condom externe mâle comprenant une partie conique et une partie gaine, cette dernière étant constituée d'uréthane et d'une épaisseur comprise entre 2 et 8 millièmes de pouce. L'invention traite aussi d'un procédé permettant de produire le cathéter à condom mâle, qui consiste à plonger une partie conique placée sur un mandrin dans un bain d'uréthane à l'état liquide, à retirer le mandrin de telle sorte qu'une partie gaine soit formée à partir de la partie conique le long du mandrin, à soumettre à une cuisson le mandrin comprenant la partie conique et la partie gaine et à répéter l'opération de plongée et de cuisson jusqu'à obtention de l'épaisseur requise de la partie gaine. Un revêtement et un adhésif de séparation peuvent également être appliqués sur la surface de la gaine avant le retrait du cathéter à condom du mandrin.
PCT/US1995/007978 1995-03-31 1995-06-22 Catheter a condom male en deux parties et procede de fabrication de ce catheter Ceased WO1996029962A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP95925301A EP0817601A1 (fr) 1995-03-31 1995-06-22 Catheter a condom male en deux parties et procede de fabrication de ce catheter
AU29482/95A AU704557B2 (en) 1995-03-31 1995-06-22 Two piece male condom catheter and method for manufacture
JP8529305A JPH11502736A (ja) 1995-03-31 1995-06-22 ２つの部分からなる男性用コンドーム型カテーテルおよびその製造方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US41418295A 1995-03-31 1995-03-31
US08/414,182 1995-03-31

Publications (1)

Publication Number Publication Date
WO1996029962A1 true WO1996029962A1 (fr) 1996-10-03

Family

ID=23640310

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1995/007978 Ceased WO1996029962A1 (fr) 1995-03-31 1995-06-22 Catheter a condom male en deux parties et procede de fabrication de ce catheter

Country Status (4)

Country Link
EP (1) EP0817601A1 (fr)
JP (1) JPH11502736A (fr)
AU (1) AU704557B2 (fr)
WO (1) WO1996029962A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004004796A1 (fr) 2002-07-08 2004-01-15 Coloplast A/S Catheter urinaire externe
WO2013117635A1 (fr) 2012-02-10 2013-08-15 Phalomed Holdings Ltd. Dispositif pour l'évacuation d'urine chez des patients masculins incontinents

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6839452B2 (ja) 2016-02-18 2021-03-10 ユーアール２４ テクノロジー，エルエルシー 自動尿採取器−分析器
US11311405B2 (en) 2020-05-22 2022-04-26 Ur24Technology, Inc. Methods and apparatus for collecting body fluids
USD969308S1 (en) 2020-05-28 2022-11-08 Ur24Technology, Inc. Fluid collection apparatus
USD1034968S1 (en) 2022-10-31 2024-07-09 Ur24Technology, Inc. Fluid collection apparatus
USD1034967S1 (en) 2022-10-31 2024-07-09 Ur24Technology, Inc. Fluid collection apparatus

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3520305A (en) * 1967-04-24 1970-07-14 Ray D Davis Male urinary device
GB2048680A (en) * 1979-05-10 1980-12-17 Craig Med Prod Ltd A male incontinence device
GB2152380A (en) * 1981-09-29 1985-08-07 Downs Surgical Plc Incontinence appliance for male personal wear
US4626250A (en) * 1981-06-05 1986-12-02 Hollister Incorporated Male urinary collection system and external catheter therefor
EP0335564A1 (fr) * 1988-03-28 1989-10-04 Hollister Incorporated Sonde urinaire masculine externe et insertion antimicrobienne pour cette sonde
EP0666070A1 (fr) * 1994-02-02 1995-08-09 E.R. Squibb & Sons, Inc. Dispositif d'incontinence masculine

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1989004647A1 (fr) * 1987-11-13 1989-06-01 Stillman, Suzanne Articles prophylactiques a enrobages biocompatibles

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3520305A (en) * 1967-04-24 1970-07-14 Ray D Davis Male urinary device
GB2048680A (en) * 1979-05-10 1980-12-17 Craig Med Prod Ltd A male incontinence device
US4626250A (en) * 1981-06-05 1986-12-02 Hollister Incorporated Male urinary collection system and external catheter therefor
GB2152380A (en) * 1981-09-29 1985-08-07 Downs Surgical Plc Incontinence appliance for male personal wear
EP0335564A1 (fr) * 1988-03-28 1989-10-04 Hollister Incorporated Sonde urinaire masculine externe et insertion antimicrobienne pour cette sonde
EP0666070A1 (fr) * 1994-02-02 1995-08-09 E.R. Squibb & Sons, Inc. Dispositif d'incontinence masculine

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004004796A1 (fr) 2002-07-08 2004-01-15 Coloplast A/S Catheter urinaire externe
WO2013117635A1 (fr) 2012-02-10 2013-08-15 Phalomed Holdings Ltd. Dispositif pour l'évacuation d'urine chez des patients masculins incontinents

Also Published As

Publication number Publication date
AU704557B2 (en) 1999-04-29
JPH11502736A (ja) 1999-03-09
EP0817601A1 (fr) 1998-01-14
AU2948295A (en) 1996-10-16

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